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Method and apparatus for treatment of neurodegenerative diseases including depression, mild cognitive impairment, and dementia

a neurodegenerative disease and treatment method technology, applied in the field of neuromodulation, can solve the problems of increasing the risk of suicidal thinking or behavior in some young adults, the use of drugs that do not replicate the normal physiological events at synaptic junctions can have significant untoward clinical effects, and the term is often inaccurately used

Inactive Publication Date: 2011-04-28
NEUROMED DEVICES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

One or more embodiments of the invention enable a method and apparatus for treatment of neurodegenerative diseases including depression, mild cognitive impairment, and dementia.
An apparatus and methods for treating patient ailments in various aspects of neurological disorders delivers electrical stimulation coupled with alternating high and low frequencies to the skin or mucosa of a patient so as to produce non-invasive therapeutic neuromodulation. Systemic neuromodulation is produced by a series of electrical pulses having various electrical characteristics coupled with alternating frequency outputs. The apparatus includes a housing having at least two electrodes supplied with either or both AC and DC voltages. The AC voltages have various patterns and ranges of output frequencies. Devices will be powered by an internal bat

Problems solved by technology

In May 2007, The Food and Drug Administration ordered drug makers to add warnings to antidepressant medications, saying the drugs increase the risk of suicidal thinking or behavior in some young adults.
Hence the use of drugs that do not replicate the normal physiological events at synaptic junctions can have significant untoward clinical effects.
However, this term is often inaccurately used to describe the mechanisms of action of treatment drugs, such as SSRI antidepressants, that claim they are able to increase the supply of serotonin at synaptic junctions.
At the present time, despite claims by some pharmaceutical companies, no drugs can increase the production of naturally synthesized neurotransmitters in the human nervous system.
This non-physiological process has its own clinical complications.
In Alzheimer's disease, amyloid plaques build up in brain tissue over time, causing increasing symptoms of dementia.
However, both these methods involve invasive, risky and complex surgical techniques.
In spite of the regulatory approval in 1997 of such brain implants for use in the control of essential tremor, there is no evidence that this approach can produce neurochemical modulation.
When used to control essential tremor, an implant in one thalamus can only stop hand tremor in one hand positioned contralateral to the implant in about 30% of the cases Furthermore, the implant cannot stop bilateral hand tremors or head tremor, as can non-invasive neuromodulation (Silverstone et al, 1998).
In addition to increased risk, patients who received deep brain stimulation lost some verbal fluency, memory, and information processing speed.
A further disadvantage of this approach is the high cost of surgery; it costs about $65,000 to implant the electrodes.
Once implanted, in the event of negative side effects, even a single implant cannot be removed.
Electroshock therapy uses high levels of electrical stimulation to induce seizures, resulting in severe side effects such as memory loss and confusion.
The use of electroshock therapy is limited due to the extreme effects and there is no evidence that this treatment approach can produce neurochemical modulation.

Method used

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  • Method and apparatus for treatment of neurodegenerative diseases including depression, mild cognitive impairment, and dementia
  • Method and apparatus for treatment of neurodegenerative diseases including depression, mild cognitive impairment, and dementia
  • Method and apparatus for treatment of neurodegenerative diseases including depression, mild cognitive impairment, and dementia

Examples

Experimental program
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Effect test

example 1

Table 1 comprises a series of frequencies and specified time periods for an exemplary treatment profile. A single frequency sweep changes from 10 KHz, up to 100 KHz, and after a series of changes, which ascend and descend in frequency output, finally cease at the lowest frequency, which can be 1 Hz, or 0.1 Hz, or any lower number. In Example 1, the frequency is rapidly lowered at each decreasing step compared to the rate of increase at each increasing step. The entire frequency sweep occurs over a duration of 60 minutes. FIG. 4 presents a graph of the frequency sweep over a 60 minute treatment cycle generated from the treatment profile of Table 1, wherein the frequency is adjusted linearly over each time period. Alternatively, the frequency is adjusted non-linearly between frequencies.

TABLE 1StartTime(Hz)End (Hz)(sec)10,000100,00010100,00040,0002040,00045,000545,00030,0002030,00035,000535,00025,0002025,00030,000530,00020,0002020,00025,000525,00015,0002015,00016,000216,00010,0002510,...

example 2

Treatment of Clinical Depression

A treatment program comprising treatment cycles based on a treatment profile for clinical depression is described. Treatment of clinical depression includes treatment of symptoms, prevention, and controlling clinical depression.

Table 2 comprises a series of durations and frequencies in an exemplary treatment schedule to treat clinical depression. The treatment profile comprises 3 phases, corresponding to a high intensity phase, a moderate intensity phase, and a low intensity phase.

TABLE 2Exemplary treatment profile for clinical depression treatment profileFrequencyPhasedurationtime(KHz)10105580510305153552020525255301253514540825459105545604.520802.55852.8301151351201.2701900.851950.9802750.652800.65803600.35

FIG. 5 presents a graph of the frequency sweep over a treatment cycle generated from the treatment profile of Table 2, wherein the frequency is adjusted linearly over each time period. Alternatively, the frequency is adjusted non-linearly between ...

example 3

Treatment of Cognitive Impairment

A treatment program comprising treatment cycles based on a treatment profile for mild cognitive impairment and dementia is described. Treatment of mild cognitive impairment and dementia includes treatment of symptoms, prevention, and controlling clinical depression. Table 4 comprises a series of durations and frequencies in an exemplary treatment schedule to treat mild cognitive impairment and dementia. The term cognitive impairment is used broadly to cover both mild cognitive impairment and dementia.

TABLE 4Exemplary treatment profile for cognitive impairmentFrequencyPhasedurationtime(KHz)10106680612603156562145324501034303373523601525651730951051001235135710145835180335185455240252452.5553001.553052553600.4

FIG. 6 presents a graph of the frequency sweep over a treatment cycle generated from the treatment profile of Table 3, wherein the frequency is adjusted linearly over each time period. Alternatively, the frequency is adjusted non-linearly with res...

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Abstract

A method and apparatus for treatment of neurodegenerative diseases including depression, mild cognitive impairment and dementia. An electrical signal comprising a stimulation frequency is generated and applied transcutaneously to a patient over at least one treatment cycle comprising a plurality of intervals, wherein each interval comprises increasing the stimulation frequency to a high frequency and decreasing the stimulation frequency to a low frequency.

Description

BACKGROUND OF THE INVENTION1. Field of the InventionEmbodiments of the invention described herein pertain to the field of neuromodulation. More particularly, but not by way of limitation, one or more embodiments of the invention enable a method and apparatus for treatment of neurodegenerative diseases including depression, mild cognitive impairment, and dementia.2. Description of the Related ArtThe human brain is made up of a trillion cells, one hundred billion of them being neurons linked in a vast network. Neurons receive signals on highly branched extensions of their bodies called dendrites and send the information along a single extension called an axon. Axons are microscopic in size but can be up to two meters in length, and branch into multiple terminals that synapse with many different cells. Communication along individual nerve cells occurs by electrical impulses called action potentials. Communication between nerve cells occurs at synaptic junctions, where neurotransmitters...

Claims

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Application Information

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IPC IPC(8): A61N1/36
CPCA61N1/36025
Inventor SILVERSTONE, LEON M.
Owner NEUROMED DEVICES
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